combination chemotherapy in treating patients with germ cell tumors that have not responded to previous cisplatin

Conditions: Ovarian Cancer; Testicular Germ Cell Tumor

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i/ii trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular germ cell tumors that are refractory to platinum-containing chemotherapy.

objectives: * determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin. * determine the efficacy of this regimen as salvage therapy in these patients. outline: this is a dose escalation study of paclitaxel. patients receive paclitaxel iv continuously on day 1 and cisplatin iv over 20 minutes and ifosfamide iv over 30 minutes on days 2-6. filgrastim (g-csf) is administered subcutaneously (sc) on days 7-18 or until blood counts recover. treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. additional patients receive paclitaxel at the mtd. after completion of chemotherapy, some patients may undergo resection of residual masses. projected accrual: a total of 18-43 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: * histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen * active disease meeting 1 of the following conditions: * measurable or evaluable disease * elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin) * unresectable residual disease after postchemotherapy surgery * favorable prognostic factors for achieving a complete response (cr) to cisplatin-based salvage therapy required, including all of the following: * no more than 1 prior regimen or 6 prior courses of cisplatin * testis or ovarian germ cell primary site * prior cr to cisplatin therapy * incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin patient characteristics: age: * 15 and over performance status: * not specified life expectancy: * not specified hematopoietic: * wbc at least 3,000/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 8.0 g/dl hepatic: * not specified renal: * creatinine clearance greater than 50 ml/min * renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator cardiovascular: * if history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry other: * no active infection not well controlled on antibiotics prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * no prior paclitaxel or ifosfamide * at least 3 weeks since prior chemotherapy * no other concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * not specified surgery: * see disease characteristics * recovered from recent surgery

Keywords: recurrent malignant testicular germ cell tumor recurrent ovarian germ cell tumor